Exoskeleton-Assisted Walking ExoAtlet II

Not Applicable

Withdrawn

• Conditions: Spinal Cord Injuries
• Interventions: Device: ExoAtlet II

• Registration Number: NCT04532723
• Lead Sponsor: Craig Hospital

Brief Summary

Based on prior exoskeleton research, it was determined that 40 participants of variable height, weight and injury level would provide a significant measure of the safety and feasibility of using the ExoAtlet II in individuals with SCI for standing and walking rehabilitation therapy. Craig Hospital will be responsible for enrolling up to 30 individuals during the study duration.The inclusion criteria will be utilized to identify appropriate subjects for this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Start: 2021-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-26
• Primary Completion: 2023-07
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D)

• 18 Years of age or older in general good health

• Weight, no more than 220lbs (100kg)

• Intact Skin

• Able to stand without exhibiting symptomatic hypotension

• Use a wheelchair for mobility at least 50% of the day

• Enough strength in hands and shoulders to support standing and walking using crutches or a walker

• Medical clearance for full weight-bearing

  ---Per our clinical guidelines, we will require all individuals with SCI who are going to use an exoskeleton to receive full weight-bearing medical clearance from their physician prior to participation. If they are unable to obtain full weight-bearing medical clearance they will not be able to participate in this study.

• Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid

• Hip width no greater than 18" (46 cm) measured when sitting

• Femur length between 37 cm and 49 cm measured between mid-patellar tendon and the floor

Exclusion Criteria

• Spinal cord injury level higher than T4 (AIS A-C) or C7 ASIA D

• Severe muscle stiffness/tightness

• Significant spasticity (Modified Ashworth Scale score of 3 or above)

• Trunk or lower extremity pressure wound

• Unstable spine, un-healed limbs, or fractures

• Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints

  ---Each individual who is interested in participating in this study will be screened for heterotropic ossification (HO) using a verbal checklist first and then they participate in a thorough range of motion (ROM) evaluation before being fit in the exoskeleton. If they verbalize a history of HO or demonstrate a bony block/resistance to passive ROM, they will be sent back to their physician to rule out HO and will not participate in the study until they receive additional clearance.

• Joint instability, dislocation, moderate to severe hip dysplasia

• Uncontrolled seizures

• Fracture or lower-limb surgery in past year

• Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton

• Pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ExoAtlet II	ExoAtlet II	Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI

Primary Outcome Measures

Name	Time	Method
Change in Skin Integrity	change from baseline skin integrity at 2 weeks	Skin breakdown
Change in Fractures	change from baseline number of fractures at 2 weeks	Number of fractures and cause
Change in Falls	change from baseline number of falls at 2 weeks	Number of falls

Secondary Outcome Measures

Name	Time	Method
Spasticity	Baseline, Week 1, Week 2	Modified Ashworth
Standing Time	Baseline, Week 1	Upright and weight bearing total time
Ambulation Time	Week 1	Total walking time
Standing Assistance	Baseline, Week 1	level of assistance in standing
6 Minute Walk Test	Week 1	Total distance walked in 6 minutes
Physical Activity Enjoyment Scale	Baseline, Week 1, Week 2	Scale of participant enjoyment in the moment. 7-point bipolar rating scale, eleven items are reverse scored. Higher total score reflect greater levels of enjoyment
Heart Rate	Baseline, Week 1	Heart rate beats per minute
10 Meter Walk Test	Week 1	total time to walk 10 meters
Blood pressure	Baseline, Week 1	Blood pressures mm/Hg
Ambulation Assistance	Week 1	Level of assistance for walking
BORG Rate of Perceived Exertion	Baseline, Week 1	Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant